Daily Newsletter

02 January 2024

Daily Newsletter

02 January 2024

Sequana Medical’s alfapump set for FDA review

The Belgian company has submitted a premarket approval application for its already CE-marked device, with FDA approval anticipated by H2 2024.

Robert Barrie December 28 2023

Sequana Medical has submitted a premarket approval (PMA) application to the US Food and Drug Administration (FDA) for its implantable alfapump device.

The pending approval is for use in patients with recurrent or refractory ascites due to liver cirrhosis, according to a 28 December press release.

A decision by the agency is expected in the second half of 2024, according to Sequana’s CEO Ian Crosbie.

Belgium-based Sequana’s alfapump system has already been in use in Europe for over a decade, having received CE mark approval for the same indication in 2011. It received breakthrough device designation by the FDA in 2019.

The pending application for US market approval is supported by the results of a pivotal POSEIDON study. The trial (NCT03973866), which enrolled 69 patients with recurrent or refractory ascites due to liver cirrhosis, met its primary effectiveness endpoints and primary safety endpoints.

Recurrent or refractory ascites is a severe condition characterised by the build-up of fluid – in some cases an extra 15 litres – in the abdomen. The alfapump system automatically collects the fluid and moves it to the bladder to be eliminated through urination. Sequana says the device could become the first active implantable medical device in the US to conduct this task.

Currently, treatment involves invasive procedures that use a needle to drain ascites from the abdomen.

Sequana’s CEO Ian Crosbie said: “Data from our North American pivotal study demonstrate the potential for alfapump to transform the lives of these patients by virtually eliminating the need for paracentesis and delivering clinicially important improvements in quality of life. We anticipate FDA approval in the second half of 2024.”

Sequana states that the North American market for recurrent or refractory ascites due to liver cirrhosis is estimated at 78,000 patients in 2025. This number is expected to grow at 6-7% per year, reaching over 170,000 patients in 2035. The increase in the prevalence of non-alcoholic steatohepatitis (NASH) / metabolic dysfunction-associated steatohepatitis (MASH) is a key driver of the market.

In July 2023, the company announced plans to increase focus on its other lead candidate for congestive heart failure patients. Sequana’s MOJAVE is a randomised Phase I/IIa trial in the US to evaluate the use of its direct sodium removal (DSR) platform. The trial received Investigational New Drug (IND) clearance in May 2023.

Viewing the world’s data by themes makes it simpler to make crucial choices and predictions

GlobalData's latest thematic report will help you to understand and identify the important themes that threaten to disrupt your business in 2024. Our 2024 theme map covers not only disruptive tech themes but also ESG, macroeconomic, and regulatory themes. Reading this report is the first step towards making better business decisions in 2024.

Newsletters by sectors

close

Sign up to the newsletter: In Brief

Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Thank you for subscribing

View all newsletters from across the GlobalData Media network.

close